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FDA 510(k)

CONTOUR HEALER

K-Number: K112099 · 2012-02-03

ApplicantContour Healer, LLC
Decision Date2012-02-03
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CONTOUR HEALER is the device name listed in this FDA 510(k) record. The listed applicant is Contour Healer, LLC. It received FDA 510(k) clearance on 2012-02-03 under 510(k) number K112099. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTOUR HEALER?

CONTOUR HEALER is a medical device that received FDA 510(k) clearance on 2012-02-03. The listed applicant is Contour Healer, LLC. The 510(k) number is K112099.

When did CONTOUR HEALER receive FDA 510(k) clearance?

CONTOUR HEALER received FDA 510(k) clearance on 2012-02-03, under 510(k) number K112099.

Who is the listed applicant for CONTOUR HEALER?

The FDA 510(k) record lists Contour Healer, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTOUR HEALER?

The FDA product code for CONTOUR HEALER is NHA.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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